MAUDE Adverse Event Report: MALEM MEDICAL MALEM BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS

Device Problems Melted (1385); Unexpected Therapeutic Results (1631)

Patient Problems Burn(s) (1757); Therapeutic Response, Decreased (2271)

Event Date 05/02/2017

Event Type  Injury  

Event Description

I had a terrible experience with junk product that i bought online at (b)(6).The product is called the malem bedwetting alarm, blue color which was advertised online as a device to cure children's nighttime peeing in the bed.The product has no age guidelines.I used it for my (b)(6) year old child thinking it will train him from nighttime peeing habits, instead it's proven to be a harmful and terrible experience for him.The alarm has poor quality plastic that got melted with the batteries causing him harm.He not only got burn marks on his neck due to the melted plastic but started peeing in his pants in the morning too.How come the alarm can be so dangerous that it leads your child to the hospital bed for two days? i think these are just gimmick things made to fool people, playing with children's lives and making them horrified.There should be strict call on this bedwetting store who sell such life threatening device s for children with no support when you call them and want to talk to them.Fda should take a fast route to investigate this issue keeping in mind the safety of other children.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6547329
• MDR Text Key: 74629424
• Report Number: MW5069568
• Device Sequence Number: 1
• Product Code: KPN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 05/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 39 MO